Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya
- Registration Number
- NCT02188953
- Lead Sponsor
- Kenya Medical Research Institute
- Brief Summary
The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.
- Detailed Description
Aflatoxins are harmful by-products of the molds Aspergillus flavus and A. parasiticus and are major contaminants of agricultural produce such as maize. Acute aflatoxin exposure (i.e., aflatoxicosis) can lead to jaundice, vomiting, abdominal pain, and liver failure, with documented fatality rates as high as 40%. Kenya experiences extreme aflatoxin exposure and fatal, recurring aflatoxicosis outbreaks. Numerous clinical trials have found heat processed calcium dioctahedral smectite clay \[i.e., Air Classified Calcium Silicate (ACCS100)\] to be safe and effective in binding to aflatoxin to decrease bioavailability and subsequently reduce toxin-induced effects. The investigators propose to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population. If successful, ACCS100 could be scaled-up for use in Kenya to prevent aflatoxin-associated mortality during high-risk periods. To accomplish this objective, the investigators will recruit fifty health adults into a crossover study. Each participant will spend one week consuming ACCS100 and one week consuming a calcium carbonate placebo. Daily first morning void urine samples will monitor effectiveness in reducing aflatoxin bioavailability, and periodic questionnaires will assess acceptance and palatability.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Adult ≥18 years of age
- Consumes corn- and/or peanut-derived foods at least four times per week
- No plans to travel away from the household for more than one day in the next month
- Women who may be pregnant
- History of medical illnesses
- Presence of protein or glucose in urine using chemstrip
- Does not provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Calcium carbonate Calcium carbonate placebo Participants will consume 1 gram of calcium carbonate at each meal (up to three times per day) for seven days. The calcium carbonate will be administered by mixing a powder sachet into water. ACCS100 ACCS100 Participants will consume 1 gram of ACCS100 at each meal (up to three times per day) for seven days. The ACCS100 will be administered by mixing a powder sachet into water.
- Primary Outcome Measures
Name Time Method Change from baseline of urine aflatoxin M1 levels Daily during each study arm Urine samples will be collected at baseline (Day 0) and daily for seven days during Arm 1 (Days 1-7). Urine samples will also be collected at baseline (Day 13) and daily for seven days during Arm 2 (Days 13-19).
- Secondary Outcome Measures
Name Time Method Acceptability questionnaire End of arm 2 (Day 20) End of arm 2 (Day 20)
Daily diary and adverse event reporting form Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20) Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)
Serum aflatoxin B1-lysine adduct levels Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20) Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20).
Palatability questionnaire End of arm 1 (Day 8) and end of arm 2 (Day 20) End of arm 1 (Day 8) and end of arm 2 (Day 20)
Trial Locations
- Locations (1)
Makindu Health Center
🇰🇪Makindu, Kenya